Exploration of Therapeutic Strategies for NeoRAS Wild-type Metastatic Colorectal Cancer Based on Circulating Tumor DNA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-28

Study Completion Date

2028-09-01

Brief Summary

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Following systemic therapy in metastatic colorectal cancer(mCRC),RAS (including KRAS, NRAS and HRAS gene) status may change from a mutant(MT) to a wild-type(WT),a phenomenon known as "NeoRAS WT"mCRC.NeoRAS WT can be detected by longitudinal circulating tumor DNA(ctDNA) analysis.Therefore, this prospective phase II Study was design to explore the detection rate of peripheral blood ctDNA testing for NeoRAS WT and its guiding value for subsequent treatment for mCRC.

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Detailed Description

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Conditions

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Colorectal Cancer Metastatic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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RAS mutated metastatic colorectal cancer

RAS mutated metastatic colorectal cancer were routinely treated after enrollment. When the disease progression was confirmed by imaging, peripheral blood ctDNA detection was performed to observe whether they were transformed into NeoRAS wild-type patients. If NeoRAS wild- type was detected, the anti-EGFR therapy may be considered as the following therapy for patients.

Group Type EXPERIMENTAL

Cetuximab

Intervention Type DRUG

Cetuximab is given In patients with NeoRAS WT

Interventions

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Cetuximab

Cetuximab is given In patients with NeoRAS WT

Intervention Type DRUG

Other Intervention Names

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C225

Eligibility Criteria

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Inclusion Criteria

1. Metastatic colorectal cancer with tissue RAS mutation-type;
2. ECOG (Eastern Cooperative Oncology Group) performance score is 0-1;
3. Obtaining informed consent;
4. Surgical specimens or punctured tissue specimens containing tumors can be obtained; 10ml of peripheral blood can be obtained

Exclusion Criteria

1. The pathology was not confirmed by colonoscopy biopsy or biopsy of metastasis;
2. Colorectal cancer patients with clinical stage I-III;Patients with RAS wild-type metastatic colorectal cancer confirmed by histological genetic testing;Lack of adequate organ functions, such as severe abnormalities in blood, liver and kidney function

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No